Package of outer unsterile and inner sterile convers for enclosing a substantial portion of an object having an unsterile surface



June 4, 1963 .1. L. BRAUsE ETAL 3,092,252

PACKAGE OF OUTER UNSTERILE AND INNER STERILE COVERS FOR ENCLOSING ASUBSTANTIAL PORTION OF AN OBJECT HAVING AN UNSTERILE SURFACE Filed May22, 1961 3 Sheets-Sheerl 1 C, e f

aoc'

INVENTORS. Jc/oblZErazzse I lll# l I lv xga@ June 4, 1953 J. l.. BRAUSEETAL 3,092,252

PACKAGE OR OUTER UNSTERILE AND INNER sIERILE COVERS FOR ENCEOSINC AsuBsIANIIAL. PORTION OE AN OBJECT HAVING AN UNsTERILE SURFACE Filed May22, 1961 5 Sheets-Sheet 2 June 4, 1963 J. l.. BRAUSE ETAL 3,092,252

PACKAGE OE OUTER UNSTERTEE ANO INNER sTERIEE COVERS ROR ENCEOSTNC ASORSTANTTAL PORTION OF AN OBJECT HAVING AN UNSTERILE SURFACE Filed May22, 1961 United States Patent Otiice 3,092,252 Patented June 4, 19633,092,252 PACKAGE OF OUTER UNSTERILE AND INNER STERILE COVERS FORENCLOSING A SUBSTAN- TIAL PORTION OF AY OBJECT HAVING AN UNSTERILESURFACE Jacob L. Brause, 5724 Moreland St. NW., Washington, D.C., andWaiter W. Burns, 611 Main St., Greeuport, Long Island, N.Y. (856 WarnerBldg., Washington 4,

' Fired May 22,1961,ser.Ne.119,as9

s eiaims. (ctms-ssa) This invention relates to a package containing anenvelop within an outer protective enveloping member, the latterenveloping member protecting the outer surface of the inner envelopafter it has been rendered aseptic or has vbeen sterilized so that itmay be contacted by the -animal tissue of a human being or animalWithout permitting cross-contamination by any pathological bacteria orvirus which might be otherwise attached to or on the surface of anoperative object within the inner envelop.

The invention is applicable on a wide scale and may be used forpreventing cross-contamination by a clinical thermometer, a tonguedepressor or other object, as for example, the human hand which it maybe necessary t insert into the human oral cavity.

In the use of clinical thermometers, for example, as in the home or inhospitals, there is always a problem in having the thermometer asepticor sterile. This problem is more acute Where the thermometer is used inthe mouths of a plurality of patients, any one of which may be a carrierof some disease, the pathological bacteria `or virus of which may belodged in the mouth of a patient using the thermometer. In the past,certain precautions have been taken to kill or render ineiective thebacteria or virus, after and/or before the use of the thermometer byeach patient. It has been found that these precautions have not alwaysbeen effective.

LFor this reason and to make the thermometer or other operative objectsafe for use, the problem has been lapproached from the point of View ofmaking the use of the thermometer or other object safe for use in thepatients mouth, even though no effort has been made to make the surfaceof the thermometer `or other operative object aseptic or sterile, priorto its use.

In describing this invention, We have used the term object or operativeobject for the reason that the invention is one which may be operatedWith a clinical thermometer, a tongue depressor or some other ysurgicalor medical device or by the human hand, as when the cover is used toprotect the mouth or -lips from infection from the human hand.

The term aseptic or sterile is meant to describe and include theconditions existing on the outside Wall of the inner envelop and theinside Wall of the outerenveloping member as the inside envelop and theoutside envelop form the protective package. These conditions are meantto include all conditions Which, however produced, would not transmit,by contact thereof, any injurious or contamination disease caused bypathological bacteria or virus. The conditions may be brought about byany suitable method. Included are irradiation, gas application eitherdirectly or indirectly through the Wall of an enveloping or envelopmember, sterilizing or aseptic con- 2 dition-producing powders orliquids which are not injurious to human beings.

The primary object of this invention is the production of a clean, tightcontainer or cover for that portion of the thermometer or otheroperative object from coming into contact with the human body, as in themouth or rectum, and which has been or may be previously made sterile oraseptic to prevent cross-contamination and the spread of pathologicalbacteria or virus, thus preventing spread of disease.

Still another object of the invention is the production of a exiblecover for a clinical thermometer or other operative object Which coverwill have a clean sterile, aseptic surface for contacting the human bodyand protecting the thermometer or other operative object from cominginto contact with the human body while in use, the cover having aprotecting enveloping member for maintaining the sterile asepticcondition.

A still further object of the invention is the production of adisposable flexible cover for a clinical thermometer or other operativeobject having a protecting enveloping member for protection of thecontacting surface until contact is made with the human body as it isused, the cover and enveloping member having adjacent sterile asepticsurfaces to prevent cross-contamination of the human body from thethermometer or other operative object.

Still another object of the invention is the production of a relativelyimpervious `sterile aseptic cover for clinical thermometers lor otheroperational objects for preventing the thermometer or other object fromtouching the human body, the cover only contacting the human body whenin operation and an enveloping member for the cover to maintain theaseptic sterile condition until used.

Still another object of the invention is the production of a packagehaving an inner cover and an outer enveloping member surrounding thecover, the outer enveloping member being of a type to permit therendering of the outer surface of the cover member laseptic and sterilewithout removing the outer enveloping member from the inner `covermember.

A further object of the invention is the production of a cover forclinical thermometers or other operative objects, the cover having aheat-conducting body and a sterile aseptic outer surface, the outersurface of the cover being protected by an outer enveloping member forenclosing the cover and protecting the sterile aseptic surface fromcontamination until time for use.

A further object of the invention is the production of a packagecomprising an inner enveloping cover for clinical thermometers lor otheroperative objects, the outer surface of the inner -cover being renderedsterile, aseptic in lany suitable manner such `as by sterilizing theouter surface of the inner cover by irradiation or by `suitable gasapplication thereto, by penetration through fthe body of an youterenveloping protecting member which envelops the inner cover member, orby coating the inner cover with `any suitable sterilizing liquid orpowder which is not objectionable as dangerous or distastefu andcontinuing the protective envelopment of the inner cover member untillsuch time as it may be used.

A yfurther object of the invention is the provision of a cover for aclinical thermometer or other operative ol ject where the obiect wouldcome into contact with the human body, the rcover having Xa clean,sterile, aseptic metallic surface to contain the operative object, therebeing a non-electric-conducting snrliace to protect the teeth fromgalvanic action, an outer enveloping member covering the cover member=to protect and maintain its ase-ptic, sterile, clean condition.

Still another and further object of the invention is the provision of amethod of protecting the mouth of the user against pathologicalbacteriological or virus infection or contamination, which comprises themaking of an inner relatively impervious envelope or cover -ofheattransmitting material for receiving the bulb-end of a clinicalthermometer, the placing of a non-galvanic material over the area'w'hichwould come into `Contact with the teeth of the user, `the placing of asecond enveloping member over the rst inner envelope or cover, therendering of 'the lpackage #tree of pathological bacteria, virus, zandother micro-organisms Which might transmit disease, ,the opening of ftheouter enveloping member, the insertion of the thermometer into the innercover or envelope and the removal of 'both the thermometer and the innerenvelope as 'a unit, with the thermometer there- Y -in and placing theunit into the mouth of the patient without touching the mouth-contactingportion of the inner envelope or cover with the hand of the operator, orany other operative object of possible contamination.

Still another and further object of the invention is theA provision of amethod of protecting fthemouth of the user of a clinical thermometer orother operative object against contamination, which comprises the making|of a sterile Vaseptic inner envelope or cover of heatfftransmit- Ytingmaterial for thel bulb-end of ta clinical thermometer,

or other openative object, of placing this cover in an enveloping memberuntil time for use, the rendering of the outside of the envelope orcover clean -by sterilization or other suitable method, the removal ofthe outer enveloping member and the placing of the thermometer or otheroperative object into the inner cover or envelope and insertion of fthethermometer and cover into the mouth of the patient, the thermometer orother operative object being inside theV envelope or cover when soplaced.

Other and further objects of the invention will be lapp-arent to :thoseskilled in the lart from a reading of the complete specification.

Referring to the ldrawing wherein we have illustrated embodiments of ourinvention:

FIG. 1 is a plan view of one form of our invention,

showing an inner envelope without the insulator to guard againstgalvanic action: FIG. 2 is Ia View taken from ythe iline 2-`-'Z ofFIG. 1. FIG. 3 is a `greatly enlarged sectional view on the line 3--3ofFIG. l. FIG. 4 is a view similar to FIG. l but hav-ing the insulator inplace ,toA guard the teeth fillings of the user against galvanic actionand showing the position of the clinical thermometerwhen in place.

FIG. `5 is lav sectional view taken between/the folds of the innerenvelope of FIG. 4, and taken with the clinical thermometer in place.

FIG; 6'is a view of the outer envelope with the posi- Ition of the innerenvelope indicated.

Y FiG. 7 is la sectional View taken on the Iline 7-7 of FIG. 6 and muchenlarged.

FIG. 8 -is a detail cut-away view of the fold at each end. ofwthe outerenvelope, as shown in FIG. 6.

f 4 end of the inner envelope, the fold 'being somewhat simi- Ilar tothat of FIG. 8.

FIG; l2 is a plan view of the package showing a modied form of`one-piece tubular inner cover member and a modified form of outerpackage with aps for opening .the outer enveloping member to expose toview the inner cover member. y

FIG. 13 is a cross-sectional view of the package taken on the line 13-I3of FIG. 12.

FIG. 14 is a longitudinal sectional view taken on the line 14--14 ofFIG. 12.

FIG. 15 is a modified form of the invention showing the linner covermember made large enough to receive Va tongue depressor 36 'and with theouter enveloping member indi-cated conventional-ly in dottedv lines at37.

FIG. 16 is a modified form of inner cover member which is closed `atboth ends and is provided with ya weakened line to aid in opening.

FIG. 17 is la view of the inner cover member shownin FIG. 16 but withthe lap torn over land with a `clinical thermometer therewithin, readyfor use.

FIG. 18 is a pattern of the inner cover member shown in FIGS. 16 and 17.

FIG. 19 is a view of an outer enveloping member with an opening flapmember 47 adapted forpulling open one end of the enveloping member alonga weakened line 48, and showing the outer envelop enclosing a pair Y ofconventional inner cover members, for use if it is desired to have anurse use the pair with two clinical thermometers in the mouths ofpatients inV adjacent beds.

FIG. 2O is a side view of an inner cover member of the tubular typeshowing an opening 52 with a color to mark the-edge of the opening. Y Y

FIG. 2l is a side view taken from a point at 90 from that of FIG. 20,showing the top of the opening and a color band Vto indicate theV edgeof the opening.

FIG. 22 is a longitudinal sectional View of an inner cover member 6l)shown as being used to cover the finger 59 of a user. Y

FIG. 23 is a view of the outsideV of an inner cover.

member 60 showingY its use withv a users'tinger on the inside of theAcover member and a patch 61 of medicated material on the outside of thecover member in a position to be used by the underside of the iinger 59as indicated in dotted lines on this tigure. Y FIG. 24 is a planview ofan outer enveloping member 62 showing the inner cover member 60 indotted linesV nurse or doctor in the massage of a patients gum.

Y FIG. 9 is a1-detail view of the outer envelope with its Y end torn'away for .the insertion of the clinical thermometer, the released endportion of the outer envelope being folded back for convenience ofentering the thermometer into fthe inner envelope. Y l

FIG. 10 is a pattern of the form of the inner envelope illustrated-inFIG. 4. Y

FIG. 11 is a detail' cut-way view of the fold at the bulb- In thedrawing and specification, Vthe same reference characters refer to Vthesame or similar parts.

The illustrated construction comprises an inner cover or protectingmember for the bulb-end of a clinical thermometer, the outer surface ofwhich, at least, is sterile, aseptic clean. The terms-sterile clean,Laspeticare intended to include a condition Vin which the surface isfree from pathological bacteria virus, or other microorganisms which, ifpresent, might communicate a disease tothe user. covering or envel'opinTmember such as an enclosing fold or envelope to preserve the sterile,clean, aseptic condition of the outer surface of the inner envelope orenclosing member.y Y

The inner enclosing cover member, as an envelope, is illustrated in theinst-described embodiment `as being made from a sheet 29 as shown inFIG. l0 of the drawing. This sheet 20 is preferably provided with twoYcut- The construction also includes an outersheet 20 is of a galvanicnature or an electrical conductor. This is to prevent the formation of agalvanic battery which might take place if the sheet 20 is of metal andshould contact a metallic filling of a tooth in the mouth of the user.

The strip 20 is folded along the line C-D of FIG. l0 and the edges 26dof the fold are suitably secured together along the line E-F of FIG. 4.These edges 20d may be cemented, heat-sealed or crimped or securedtogether by any suitable or well-known method to make them moisturetight.

One end of the folded inner envelope may be, though not necessarily leftopen and the other end closed as shown in FIGS. 4, 6 and ll. The methodof closing the end of the inner envelope at the left in FIGS. 4, 6 andll may be by cementing, heat-sealing or any other wellknown or suitablemethod, after which, the end is preferably folded and sealed as at 20,as a safety precaution against accidental forcing of the clinicalthermometer through the bottom of the inner envelope. This foldedportion shown greatly enlarged in FIG. ll.

In FIG. l, we have illustrated the completed inner envelope in a simplerform without any insulating band corresponding to the band Zlib of FIGS.4 and 6. In this showing, the sheet 120 is provided with the cut-awayportions 1262- and the portions 120d are secured together as describedfor the portions d. After the portions 120d are secured together, thefolds IZGC are formed as described for the folded portion of FIGS. 4 andll.

The material for the inner envelope body portion 2t) or 120 may be ofmetal such as thin sheet tin or aluminum but may be made of any materialas a suitable plastic which is practically or suthciently impervious tomoisture and which will properly conduct heat from the mouth of a userto the bulb of the clinical thermometer when the envelope is in placeabout the bulb. When a plastic sheet is used, seams may be closed byheat-sealing.

When the band 20h is used, this band may be of suitable paper, cloth orany other material which will perform the necessary function, such as acoating of paint .or plastic which may be applied in the solid or liquidform, after which it will dry to form a proper insulating coatlng.

The outer envelope or covering is such that it will protect the innerenvelope from contamination-in other words, its purpose is to protectthe clean outer surface of the inner envelope. This outer envelope ismade from a sheet 25 with two folds forming three parts 25a, 251, 25,which overlap each other, as indicated in FiG. 7. The sheet 25 whenfolded has a space within its folds large enough to receive the innerenvelope 2i) or 120 with space to spare. There is sufficient length tothe folded outer envelope 25 at its ends to provide for a folded portionat each end as illustrated in FIGS. 6 and 8 and still leave plenty ofspace for the inner envelope 2522 In making the outer envelope, theinner envelope is inserted between the folds of the outer cover orenvelope 25 as the folds are made. At the same time, there is inserted arip cord 26 which extends the full length of the cover or envelope 2S.This cord is shown at 26 in FIG. 7, in cross section and itslongitudinal position is indicated by the dotted line in FIG. 6. It willbe observed that when the ends of the outer cover or envelope 25 arefolded as illustrated in FIG. 8 the ends of the cord 26 will be wrappedin the respective end folds. yIn this way, the ends are held firmly withrelation to their respective folds.

When it is desired tto use the clinical thermometer 15 in the mouth ofthe patient to take the patients temperature, it is not necessary totreat the outside of the thermometer each time between ordinary uses.Regardless of whether or not the thermometer has been treated to have aclean, sterile, aseptic outside surface, the inner envelope will protectthe patients system .against the infection of his mouth from anypathological bacteria, virus or other micro-organisms which may be onthe surface of the thermometer.

In use by -a right-handed person, the package as illustrated in FIG. 6is grasped by the loft Ihand, fthe right hand being used to lgnasp andtear the folded end of the outer cover or envelope along substantiallythe line A-B as illustrated in FIG. 9. As the folded end is torn off,fur- (ther movement of the `folded end away from the outer envelope willcause the trip cord 26 to tear the fold of the outer envelope which isnearest the operator. This will expose the open `end of the innerenvelope 20 and place la cut-away opening 2Q@ in position for theinsertion of the clinical thermometer 15.

The thermometer is pushed, bulb-end first, into the inner envelope untilthe bulb-end enga-ges the closed folded end 2t?c of the inner envelope20. The linner envelope is then .and not Iuntil then removed from theouter cover or envelope member 25, care being taken rto touch only thesurface of the inner envelope 20 near the open end. This is natural ifused by a right-handed person, in this manner, since the thermometer 15and inner envelope 2.0 will be held in the right hand of the operatorwhile the inner envelope 2t? is removed from the outer cover or envelope25. It is to be observed that as the rip-cor 26 cuts the `fold betweenthe folded portions 25b and 25.0, `a flap 25d `which is la part of thefold 25ad will be loosened. rIlhis fiiap 25d facilitates the entry ofthe bulb of the thermometer fto the 'inside of the inner envelope 20 bythe cut-away portion Zita.

After the inner envelope Ztl with the clinical thermometer 15 therein isfree of the outer cover or envelope 25, it is inserted in Ithe mouth ofthe patient below the tongue and the temperature taken in the usualmanner. The insulating cover member 20b will then -be in a position sothat the member 20 is of la metallic substance, cannot come into contactwith 'any imetal of a tooth or filling. If this protection were notpresent and the metallic covering of the inner envelope came intocontact with a metallic filling, Ka galvanic action would at once ftakeplace and give the patient `a very disagreeable sens ation.

No inconvenience is experienced from the ynse of the inner envelopesince this envelope should be of a material which will assist in thetransmission of the heat of -the mouth to the bulb of the thermometerand quickly bring the reading of the thermometer to Ithe temperature ofthe body of the patient or other user. After use the inner envelope Ztl,or 120, is discarded.

In rectal use, fthe inner cover member 20, is preferably wnapped aboutthe thermometer to reduce its bulk and then covered with vaseline. Inrectal use the operation of the parts is similar except that theinsulating band 20 =would have no function.

In FIGS. l2 ,and l13, we have illustrated another form of the inventionwhich has a dierent type of inner cover member and :a Idifferent type ofouter enveloping member, [either of which can be used with other andinner members or" different type according to the needs indicated.

The inner cover member is of la closed-at-one-end-type, and 'which wehave `designated by the reference character 39. It is tubular in form.This tube is of a exible material, as `a soft plastic which is softenough Ito cling close to the thermometer or other operative object. Thedimensions Aare such that a clinical thermometer may be readily insertedinto one end and long enough 'to enclose enough of the thermometer sothat the walls of the mouth will not be touched when in use. In order tofacilitate :the `insertion of the thermometer into the open-end of thetubular inner cover member 30, there is provided, at the open end, anenlarged head Silb -which will hold the side of the tubular member awayfrom the opposite side so that the opening may readily be entered by thetubular end of the thermometer to facilitate `getting it ready to placeywithin the mouth of the patient. In order to assist in this insertion,the axis of the opening 30a of the tubular member 3Q, may be made )at anangle to the axis of the Y tube 36, as shown in FIG. v1'2. Thisconstruction-will assure lthat the opening 36a is always open.

The outer enveloping member 32. (FIGS. 12, 13, 14) shown forV enclosingthe inner cover member 3@ is composedfofjtln'ee members, la main bodyportion which has two 4folded portions 32' folded on a fold 32a. 'Ilhetwo opposite sides of the portions 32 of the outer enveloping 'memberVare heat-sealed iat opposite edges to form a pocket \for the receptionof the inner cover member 30. 'Iwo removable portions 32e are sealed atthe ends of and integral with respective portions 32 -and are providedwith free flaps 321e and form la part of the enveloping member. Inoperation, these flaps are so sealed that they, while tight, areeasily'peeled ofic to expose lthe inner cover member 30 While stillleaving in place, the portion comprising the parts 32C for handling theunit without touching the inner cover member or envelop in a way tocontaminate its surface. In Iusing the package, lusually fthe strippingo of one ilap portion 32,e is sufficient to expose the inner covermember 30 for the insertion of the clinical thermometer or otheroperative object.V When so exposed, the operative object is insentedinto the inner cover member 3u land the cover member and thermometer areremoved as a unit, from the outer enveloping member and the-n insertedin the mouth of the patient, as in [the case of a `clinical thermometerto measure the temperature of the body.

FIG. 15` is a planview of an inner cover envelop, which is illustratedof a size, after opening the outer enclosing member, to enclose an endof a tongue depressor. The inner cover envelop 35 is made with a sheetof suiicient size to easily receive a tongue Vdepressor 36. The lengthof the inner cover member 35 is suicient to make an envelop large enoughto receive all of that portion of Vthe tongue depressor which wouldnormally come into contact with the mouth of a patient. The outerenveloping member is diagrammatically shown in dotted lines to indicatethat the inner cover member can Vbe used with any sui-table outerenveloping `member large enough to receive it and is not coniined to anyone form of outer enveloping member. i y

The inner cover member is here shownas an envelop Y Yhaving a singlefold 35a and being sealed, at the sides,

351n as by a suitable cement or by heat treating to seal the two edgestogether. The end 35e isopen. In use, the tongue depressor 36 isinserted into the inner cover member 35 af-terrthe outer envelopingmember 37 has been suitably opened at the open end of the inner covermember 35. vAs With the other forms of the invention, the outerenveloping member conventionally shown at 37 is held in the hand of theuser as protective means for the innercover member therein until thetongue depressor and innerrcover member 35y are removed, as a unit, fromthe outer enveloping member 37, and inserted into the mouth of thepatient. As in the other units described, some meansl for identifyingthe edge of the opening 35e is provided, as the cutting away of one sideof the opening 35e, as shown. y

Y In FIG. 16 we show an inner cover member 40 having both ends closedand having a, weakened line 46h at the end adjacent the end of the outerenveloping member which is conventionally' shown and will be opened.This inner covermember 40. may be made of one piece having a weakenedline 40-b whichV when torn along the weakened line 40h-will make adiiierently-shaped edge above its opposite edge V40C in suc-h a mannerthat an opening will be clearly presented `to the thermometer bulb 41 orthe end of the operative object to be inserted. This is shown in FIG. 17where the end 49d is torn from its original place along the weakenedline 4Gb and opened up for the insertion of the thermometer illustratedin FIG. 17. The inner cover member 40 is shown removed from the outerenveloping member 42 whichY is indicated diagrammatically in the dottedlines of FIG. 16. It will be understood that while tearing the outerenveloping member 42 open,

the outer enveloping member and the inner cover member will be heldiirrnly together to prevent touching the inner cover member with hands,thus protecting the inner cover member from cross-contamination fromthe' users hand.

HG. 18V shows the outline of a pattern of the inner cover member 40before the fold along the line 40a is made. This illustrates theposition of the dotted line 40a where the fold is to be made and alsothe weakened line 46h to assist-the tear-ing operation.

In PIG. 19 we have shown diagrammatically the use of an outer envelopingmember 44 and a plurality of conventional inner cover members45,46,therein where it might be desired, to have a plurality of innercover members within the same outer enveloping member 44, the latter tobe opened by the nurse in the presence of two patients in adjacent beds.It is understood that the particular type of inner cover member would beany illustrated cover member or its equivalent, at the option of themanufacturer, or user. In this form, We show an outer enveloping member44 having heat-sealed, cemented, glued or folded side and end edges asshown in FIGS. 6, 8, 9, and 11 but having a tab 47 at one corner toindicate the end of the outer enveloping member to be opened and tograspand hold when opening the outer enveloping member 44 along theweakened line 43. This tab member may be separate from and attached tothe corner of the outer enveloping member or it can be integral with thefold portion, as desired. n

In each of the types of inner cover members, it is preferable that theopening at the insertion end be of a typeY to show clearly, or havesome-thing to designate, the edge of the opening, whereby thethermometer bulb or other inserting end of the operative object may bemore easily inserted. In furtherance of this desire to have theoperative object easily insertable, we have shown another method inFIGS. 2'0 and 2l Where is illustrated, a'iiexible inner cover member 50of a material whichwill lie close to athermometer bulb and which has aclosedend 51 and an irregular opening 52 at the opposite end. One edgeof the opening 52, We have illustrated as being of blue color todesignate the edge of the opening nearest the open end of the tubularmember. When the inner cover: member is held within the outer envelopingmember at a point just below the opening 52, the edge of the openingmaybe easily seen and the thermometer or other opera-tive object mayeasily be inserted. This blue edge at the opening 52 of the tubularinner cover member is for the same purpose as the cutaway portions shownin FIGS. 1 and l0, and the oitaxis opening 30a of FIG. 12 or the beadededge of that'opening. f

r[he material of Ywhich the-inner cover may bemade, may be varied as toweight in order to make the inner cover member suiciently stable to holdsteady as the operative object, such as the thermometer, the tonguedepressor or the operators finger or hand is inserted, the means foridentifying the edge of the opening of the inner cover member beingvaried to adapt it to the use for which the cover'is intended. Certaingrades and weights of sheet plastics have been found to be suitable. Itis here noted that when used with a thermometer, the material of thecover member must be suiiiciently pliable to cling close to the bulb ofthe thermometer and be of a material to conduct the body heat to thethermometer bulb in order to have the'thermometer register the properreading within a reasonable time. As already poin-ted out, it isadvantageous to have the opening of the Yinner cover member clearlydefined by either a conguration of the opening or a differentiation incolor or shade. Y

YThe material forV the outer enveloping protective member which protectsthe inner cover member has a wide range in selec-tion. It is pointed outthat while some subv Vstances resist the use of irradiation as a meansof sterilizathrough some materials readily while other materials displaymarked resistance to its passage and use.

In this way a wide range in the selection of the material is permitted.However, the conditions under which the inner cover is to :be -used andthe degree of protection needed must be considered. For example, Wherethe inner cover member would be used under military field conditions,the outer enveloping protective member would be safer if made of aplastic material than if a cloth or paper enveloping member is used.

`On the other hand irradiation might not be suitable for creating anaseptic sterile situation where a heavy sheeting of some plasticmaterial is used for the outer enveloping protective member.

-For field use with the military forces, the outer protective envelopingmember would be more eicient if waterproof, iiexible and transparent.

The materials used for the respective uses should be carefullyconsidered in connection with the use to which the inner cover member isto be used and the treatment of the package as a whole prior to actualuse.

It is also pointed out that the size must be such as to readily admitinsertion of the operative object.

In this specification, and as claimed, the terms sterile and aseptic areused. These terms are not used in a limiting sense and are intended toinclude any and all means and processes which bring about conditionswithin the outer enveloping member which will protect the person oranimal with which the inner cover member is used, .from any pathologicalbacteriological organisms or viruses which would cause or result incross-contamination.

The operative object as a clinical thermometer, is inserted within theinner cover member before the latter is removed from the outerenveloping protective member, after which the operative object with theinner cover member surrounding it is inserted in the mouth of thepatient. The body heat from the mouth will be transmitted from thepatient to the thermometer bulb through the inner cover member withoutthe passage of the mouth liquid through the inner cover member.

It is here noted that some plastic sheets which are porous under someconditions to a very slight extent will be a proper protection since theplastic material of the inner cover member will, during the short timeit is in the mouth, have a tendency only to pass the mouth uid 4from themouth to the inside of the inner cover member since the pressure is allin that direction.

It is to be understood that while several types of inner envelopes andseveral types of outer envelopes are disclosed, the diiferent types ofinner envelopes may be used interchangeably with the outer envelopes ofproper size and dilerent types of outer envelopes may be -usedinterchangeably with the inner envelopes, making such changes as to sizeand form as may be needed `for the different types of operative objectsfor which the package is designed and for the types to which they are tobe put.

IIn FIG. 22 is shown an inner cover member 60 of very flexible materialsuitable for receiving an operative object as a human nger 59. A spot oflotion or massaging material 61 is provided on the outside of the innercover member 69 as shown in FIG. 23.

FIG. 24 illustrates the inner cover member 60 encased in an outerenveloping member 62 which is provided with a line 63 by which thenurses may cut the end of the outer enveloping mem-ber 62 away and missthe end of the inner cover member exposing the latter -for the insertionof the finger.

ln FlG. 25 is illustrated a detail of the end of an inner cover memberwhich may be made of thicker material and roughened to aid massage.

It is to be understood that the detailed method of producing the outersterile aseptic surface of the inner cover member, which encloses theoperative object suc-h as the clinical thermometer, is not a part ofthis invention, and ways of using material which may ibe maintained in asterile aseptic condition by treating the material before or duringmanufacture; by irradiation or by suitable gas which vwill pass throughor into the chamber between the outer surface of the inner cover memberand the inner surface of the outer enveloping member will be within theknowledge of one skilled in the chemical arts. One such agent which maybe -used is a gas, ethylene oxide,

CH2- CH2 It is particularly noted that this package is opened in thepresence of the patient and that the outer enveloping member isdiscarded when opened and the inner cover member is discarded as soon asit is taken from the patients mouth and the operative object is removed.

It is contemplated that in the use of this invention hospitals maydesire to conduct their own sterilization of the package and that theywill receive the packages ready Afor sterilization but not sterilized.

It is to be understood that the structures of FIGS. 22, 23, 24 and 25may be used with the nger and if desired, with lip-stick paste-as in abeauty parlor.

This application is a continuation in part of our pending applicationSerial Number 415,512, tiled on March ll, 1954, and now abandoned, andcontains all the disclosure of that application.

While modications have been described and illustrated in thisapplication, it is to be understood that modifications and changes maybe made without departing from the spirit of the invention and withinits scope as claimed.

Having described our invention what we claim is:

1. A package which is designed to protect the mouth of a patient fromcontamination by bacteria or virus which may be on an ope-rative objectsuch as a clinical thermometer or the like, said package comprising incombination:

(a) an inner cover member having a chamber of a size and shape toenclose a substantial portion of an operative object such as a clinicalthermometer, or the like, and protect the mouth of the patient fromcontact with the operative object,

(b) said inner cover having a closed end for insertion into the mouth ofthe patient and for holding the lower end of the operative object, whichmay be contaminated, out of contact with the patients mouth andextending outwardly beyond the mouth opening,

(c) said cover being of an impervious material, and 'of a thickness topermit ready transfer of the body heat from the patients mouth to thethermometer bulb,

(d) said material being ilexible to permit it to be readily conformed toand in contact with the outer surface of the thermometer over a largearea,

(e) an outer enveloping member having an opening indicating means andenclosing the inner cover member to enclose the same and to provideprotection therefore, the

(f) inner cover member having an outer sterile aseptic surface forseparating the operative object from contacting the mouth tof thepatient, thereby giving pro tection to the patient against bacterial andvirus contamination in the patients mouth, from the operative object,and

(g) said inner cove-r member when open lying in the outer envelopingmember in a position to permit the ready insertion of the thermometer orother operative object without removing said cover member from the outerenveloping member, and without touching t-he part of the inner covermember lwhich comes into contact with the patients mouth to anycontaminating surfaces.

2. A package which is designed to protect the mouth of a patient fromcontamination by bacteria or virus which may be on the surface ofanoperative object such as a clinical thermometer or the like, saidpackage comprising in combination:

i (a) anY inner cover member having a chamber of a 'size and shape Vtoenclose a substantial portion'of a clinical thermometer, or the like,and protect the tissue of an opening in the human body of a patient,from Contact with the said thermometer,

(.b) said cover Lhaving a closed end `for insertion into Y an `opening`oi'f the human body of a patient and for holding the bulbous end of thethermometer, which may be contaminated, out of Contact with the bodyopening, and covering said thermometer outwardly beyondthe edge of thebody opening ofthe patient,

(c) said cover being of an impervious heat conductible material, and ofa thickness suicient to permit ready transfer lof the body heat from thepatient to the thermometer bulb,

V(d) said material being ilexible thus permitting it to be readilyconformable to and in contact with a large surface area of thethermometer when inserted therein,

.(e)` an outer enveloping member for packaging the inner cover memberand enveloping the same and to provide mechanical and antiseptic andaseptic protection to the inner cover member, the

(f) inner cover member having an outer sterile aseptic surface forseparating the thermometer from contact with the body of the patient,thereby giving protection to the patient against bacterial and viruscontamination from the thermometer to the tissues of the patients body;

3. A package whichA is designed to protect the mouth of a patient fromcontaminati-on by pathological bacteria or virus which may be on anoperative object such as a clni- Vcal thermometer or the like, saidpackage comprising in combination:

(a) an inner cover member having a chamber of arsize and shape toenclose a substantial portion of an operative object such as a clinicalthermometer, or the like, and protect the mouth of the patient fromcontact WithV the operative object,

t (b) said inner cover having agclosed end for insertion into the mouthof the patient and for holding the lower outer end yof the operativeobject, which may be` contaminated, out of contact with the patientsmouth and covering said operative object outwardly beyond thepatients'mouth opening,

(c) said cover being of an impervious heat conductible material and 'ofa thickness to permit ready transfer of the body heat from the patientsmouth to the thermometer bulb,

(d) said material `being liexible thus permitting it to readily beconformable and in contact with the surface of the thermometer bulb,over a large area,

inner cover member to enveloping the same andV toV give protectiontherefor, the (f). innerV cover member havingan outer sterile asepticsurface for separating the operative `object from contacting the mouthof the patient, therebyV giving protection to the patient againstpathological kbacterial and virus contamination in the patients mouth,from the operative object, and (g) the'outer' enveloping memberrbeing inposition to permit the thermometer to be inserted into the inner coverwhile the 'outer enveloping member and inner cover member are heldtogether and itting the inner cover loosely enough to permit readyremoval of the inner coverime'mber and thermometer as a unit Vfrom theouter enveloping member without touching the mouth-contacting portion ofthe inner cover with the hands while the unit is inserted in thepatients mouth.

4. A method of protecting the human body of aipatient (a) of providingan innerrcover member having a closed end and of a size and shape to'permit ready insertion of an operative object to cover the opera- Y tiveVobject to Ia point beyond the position of the entrance to the mouth ofthe'patient when the operative object' is in the mouth, enclosed in theinner cover member, Y Y

(b) the envelopment of said inner cover member without the operativeobject by said outer enveloping member large enough to permit readyremoval of the inner cover member from the outer enveloping member,

(c) the treatment of the package by a sterilizing agent which will enterthe outer envelop and contact the outer surface of the inner covermember and render the inner cover member sterile,

(d) opening one end of the outer enveloping member, for exposing the endof said inner cover member, (e) the placing of the operative object intothe inner cover member without removing the inner cover member from theouter enveloping member,

(f) removing of the inner cover member andthe operative object, as aunit, from the outer enveloping member without permitting the innercover` member toV touch the hand or any instrumentality which mightcarry pathological bacteria or virus contamination,

g) placing the operative object and the inner cover member, as a unit,into a human body opening of the patient without removing it from theinner cover member and permitting only the uncontaminated'por'- tion ofthe inner cover member to contact the patients body orifice,

(lz) thus using the operative object for a medicalsurgical purpose,without permitting the operative object to come into contact with thepatient, and thereby t (i) protect the patient from cross-contaminationfrom -the operative object.

5. A method of protecting the human body of a patient againstpathological bacteria and virus which may be attached to the surface ofa clinical thermometer which includes the followingV steps:

(a) of providing of an inner cover member having a closed end and of asize and Lshape to permit ready insertion of a clinical thermometer tocover the thermometer to a point beyond the position of the entrance tothe mouth of the patient when the thermometer is in the mouth, enclosedin the inner cover member,

(b) the envelopment of said inner cover member without the thermometerby said outer enveloping member large enough to permit ready removal ofthe inner cover member from thel outer enveloping member,

(c) the treatment of the package by a sterilizing agent which will enterthe outer envelop Aand contact the outer surface of the inner covermember and render the said inner cover member,

(d) V-the opening of the outer enveloping member for exposing the saidinner cover member,

(e) the placing of the clinical thermometer into the inner cover memberwithout removing the innercover member from the outer enveloping member,

(f) removing of the inner cover member and the thermometer, as a unit,from the outer enveloping member without permitting the inner covermember to touch the hand or any instrumentality which might carrypathological bacteriaor virus contamination,

(g) placing the thermometer and inner cover member,

as a unit, into a human body opening of the patientV without removing itfrom the inner cover member and Y permitting only the uncontaminatedportion of the 13 nner cover member to contact the patients body orice,

(h) and using the thermometer to take the temperature of the body of thepatient Without permitting it to contact the patient, and thereby (i)protect the patient `from cross-contamination of the body from thethermometer.

References Cited in the file of this patent UNITED STATES PATENTS KargDec. 19, 1944 Karg Dec. 18, 1945 Fields Nov. 5, 1946 Perkins Apr. 14,1953 Levy July 5, 1955

1. A PACKAGE WHICH IS DESIGNED TO PROTECT THE MOUTH OF A PATIENT FROMCONTAMINATION BY BACTERIA OR VIROUS HWICH MAY BE ON AN OPERATIVE OBJECTSUCH AS A CLINICAL THERMOMETER OR THE LIKE, SAID PACKAGE COMPRISING INCOMBINATION: (A) AN INNER COVER MEMBER HAVING A CHAMBER OF A SIZE ANDSHAPT TO ENCLOSE A SUBSTANTIAL PORTION OF AN OPERATIVE OBJECT SUCH ASCLINICAL THERMOMETER, OR THE LIKE, AND PROTECT THE MOUTH OF THE PATIENTFROM CONTACT WITH THE OPERATIVE OBJECT, (B) SAID INNER COVER HAVING ACLOSED END FOR INSERTION INTO THE MOUTH OF THE PATIENT AND FOR HOLDINGTHE LOWER END OF THE OPERATIVE OBJECT, WHICH MAY BE CONTAMINATED, OUT OFCONTACT WITH THE PATIENT''S MOUTH AND EXTENDING OUTWARDLY BEYOND THEMOUTH OPENING, (C) SAID COVER BEING OF AN IMPREVIOUS MATERIAL, AND OF ATHICKNESS TO PERMIT READY TRANSFER OF THE BODY HEAT FROM THE PATIENT''SMOUTH TO THE THERMOMETER BULB, (D) SAID MATERIAL BEING FLEXIBLE TOPERMIT IT TO BE READILY CONFORMED TO AND IN CONTACT WITH THE OUTERSURFACE OF THE THERMOMETER OVER A LARGE AREA,